Joint repair system

ABSTRACT

A minimally invasive tissue incision system for creating joint capsulotomies and releasing/incising various tendon and fibrous band structures. The system contains a penetrating needle which is retractable so as to expose a cutting element, and which may be used as a penetrating needle to pierce the skin and other soft tissue structures. The cutting element provided within the penetrating needle may be used to incise subsequent tissue structures after the initial penetration. The system facilitates such procedures by providing the cutting element with the confines of the needle which provides safe introduction of the cutting element directly to the site via the needle.

CROSS REFERENCE TO RELATED APPLICATION

This application is a U.S. national stage of International ApplicationNo. PCT/US2016/024246, filed Mar. 25, 2016, which application claims thebenefit of U.S. Provisional Application No. 62/138,342, filed Mar. 25,2015, the entire contents of which are hereby incorporated by referencein their entirety for all purposes.

BACKGROUND

Joint dislocations in the human body are an increasingly commonoccurrence. Many of these dislocations involve varying degrees ofassociated ligament damage. Often, in minor injuries, the ligaments areable to heal with rest and external immobilization. However, more severeor chronic injuries to the joint require surgical intervention andinternal stabilization or “casting” of the bone forming the joint toallow for proper healing. Common joint dislocations of this type includethe acromioclavicular joint of the shoulder, which involves: (1) theacromioclavicular (AC) ligaments that join the clavicle and the acromiumof the scapula; and (2) the coracoclavicular (CC) ligaments that jointhe coracoid bone to the clavicle. Other syndesmotic joints such as thedistal tibiofibular joints are often similarly dislocated withassociated ligament damage. In the case of the AC joint injury, commonlyknown as “separated shoulder”, AC ligaments and the CC ligaments areinjured, causing upward displacement of the clavicle bone relative toboth the acromium and coracoid bones. Surgical stabilization of such aninjured joint involves the reduction of the clavicle relative to thesebones, typically via some sort of mechanism designed to pull theclavicle down into proper alignment and hold it there while healingoccurs.

Surgical techniques have been developed to accomplish this stabilizationand numerous mechanisms have been devised. For an open surgicalapproach, sutures or other band-like devices are placed around thecoracoid and attached over the clavicle. Often a tendon graft isutilized in this manner to provide a biological proxy to the injuredligaments. However, there is an ever-increasing demand for moreminimally invasive surgical techniques. Minimally invasive orarthroscopic techniques have been developed and mechanisms devised(e.g., Guerra US 2010/0125297 and Struhl U.S. Pat. No. 8,162,997) toaddress the need for minimally invasive approaches. Typically, thesemechanisms and techniques involve drilling bone tunnels through theclavicle and subsequently through the coracoid bone, then inserting asuture-based tether between the two bones held by metal buttons on theopposing sides of the bones. These procedures can be technicallydemanding and are associated with high failure rates (Cook et al., Am J.Sports MEd 2013 41: 142). The lower morbidity seen in percutaneous,endoscopic and arthroscopic surgery makes these techniques veryappealing to both patients and physicians. Often, the bone tunnelformation has been associated with bone fractures as well.

One of the primary issues with performing these surgical procedures in aminimally invasive fashion is that of access to the deep-lying bonesthat are surrounded by soft tissue. Gaining access to the opposing sideof the bone in order to place a prosthesis or passing suture is verytechnically demanding and often not possible. Others, mentionedpreviously, have attempted to solve this issue by drilling a holethrough the most surface-adjacent bone and continuing the drill holethrough the deeper lying bone. A suture construct with toggling metalbuttons is then passed through the holes in both bones, which tethersthe bones together and provides stabilization. While this can beaccomplished in a minimally invasive fashion, it can create other,structural issues. The bones may be more susceptible to fracture and ifthe holes are misaligned, there could be issues with the suture sawinginto the bone tunnel.

Passing instruments exist for circumventing bones. A typical instrumentfor passing a wire or suture under the coracoid or clavicle bones is agenerally “C-shaped” hollow needle type or corkscrew type device asdescribed by Whiteside (U.S. Pat. No. 5,501,688). It is often insertedadjacent the bone, then turned axially such that the curved portion ispositioned under the bone. A flexible wire is then passed through thelumen to complete the pass. While these types of passers work well forcircumventing a bone in the fully open surgical setting, they are verydifficult to use in confined space as in a minimally invasive procedure.

BRIEF SUMMARY

The following presents a simplified summary of some embodiments of theinvention in order to provide a basic understanding of the invention.This summary is not an extensive overview of the invention. It is notintended to identify key/critical elements of the invention or todelineate the scope of the invention. Its sole purpose is to presentsome embodiments of the invention in a simplified form as a prelude tothe more detailed description that is presented later.

Embodiments proposed herein solve the above issues by providing a jointstabilization (reduction) system and associated methods and tools forplacement of the system in an open or minimally invasive technique. Inembodiments, the joint stabilization system includes a flexibleband-like prosthesis (hereafter referred to as “prosthetic band”) forstabilizing the bones in proper position and a connector mechanism(referred to at points herein as “Connector” or “Buckle”) for joiningthe two ends of the prosthetic band around the bones. One end of theprosthetic band can be permanently attached to the connector.

Also disclosed herein as part of the system are tools that allow theplacement of the prosthetic band around the bones in a minimallyinvasive fashion. Such proposed tools include a subset or all of: (1) apassing device (herein referred to at points as “Passer”) which enablesa passing suture construct to be threaded under bones, such as theclavicle and the coracoid, though a small incision or portal; (2) acountertraction tool for facilitating tightening of the connector; and(3) a punch tool for activating a locking feature of the connector.These tools can be used with the associated prosthesis/connectorconstruct, allowing a minimally invasive stabilization of a jointseparation.

In surgical procedures to repair or stabilize the AC joint and otherjoints, some goals of an implant prosthesis can be to reduce theseparation (i.e., pull the displaced clavicle bone closer to theacromium and coracoid bones; also called “reduction”) and to stabilizethe bones in that reduced position, because the native ligaments areunable to do this job due to injury. The proposed prosthetic band ofembodiments is a wide band of suture material with strength equal to orgreater than the native ligaments. The great width of this prostheticband relative to typical suture strands allows the forces pulling thetwo bones together to be distributed over a much wider surface area onthe bones. This alleviates the danger of any “sawing” action on the bonedue to a repetitive motion.

In an embodiment, varying degrees of reduction are achievable via theconnector. To this end, connection of the two ends of the prostheticband by the connector can be either temporary and permanent. Inembodiments, the connector is permanently attached to one end of theprosthetic band and is configured such that the distal end of theprosthetic band can be removably attached to the connector, for exampleby threading the distal end through a slot in the connector and securingthe distal end under a cleat on the connector, providing a temporaryfixation/retention. The temporary fixation allows the surgeon to checkthe bone reduction to ensure its adequacy before permanently locking theconnector, for example by deforming the cleat so as to lock theprosthesis in place. This embodiment is a one-piece design with nomoving parts. Other embodiments of connectors providing both temporaryand permanent fixations can include multi-part designs with slidingbars, clamping jaws, or rotating cam-lock mechanisms, as examples. Theuse of a buckle-type connector with a prong that pierces the prosthesisband is disclosed in yet other embodiments.

Other embodiments of connectors are disclosed herein which are notbuckle-like. For example, a plate-like device can be utilized which liesacross a section of the clavicle and anchors the opposing ends of theprosthetic band. By placing attachment points to the plate-like deviceat about a 20 mm separation, the prosthetic band may be affixed in ananatomical configuration. In embodiments, temporary and permanentprosthetic band attachment features may be incorporated into the plate.In other embodiments, holes in the plate-like device may align withholes in the clavicle to accommodate placement of tendon graft.

Other embodiments of prosthetic bands are disclosed herein. In oneembodiment the prosthetic band may be a thermoplastic cable tie-likedevice with an integrated one-way connector at one end. Otherembodiments of the prosthetic band may include use of a hook-and-loopconnection mechanism.

Tendon grafts are often used in AC and CC joint repairs to augment thenative ligaments and may be used in conjunction with the prostheticbands disclosed herein. Further, prosthetic bands disclosed herein maycontain certain features to accommodate and facilitate the use of atendon graft. Strategically-placed slits in the prosthetic band mayallow a tendon graft to be placed with, though, or on top of theprosthetic band while still maintaining some contact with bone to allowtissue ingrowth. Another embodiment utilizes an open weave or a weavethat is more open in strategic locations to allow tissue ingrowth.

Prosthetic bands and configurations are disclosed herein whichfacilitate an “anatomical repair”. To this end, in embodiments,prosthetic bands and methods of installation described herein supportthe existing ligaments by placing a prosthetic(s) that mimics thenatural structure and placement of the native ligaments, for example atthe AC and CC joints. In embodiments, the prosthetic band attaches attwo attachment points on the clavicle about 20 mm apart. For example, inone embodiment, a prosthetic band may attach at one point on thecoracoid bone and diverge outward like a fan to the clavicularattachment points. In another embodiment, a singular, flexible constructis created which has a shape, such as an “X” shape, that is suited tocreate an anatomical repair. The center portion of the “X” rests underthe coracoid bone, while the legs of the “X” create the clavicularattachment points by wrapping in front of and behind the clavicle andconnecting over the superior surface of the bone. Other embodimentscreate an “anatomical repair” by placing a simple single prosthetic bandin a very specific anatomical configuration using specific methods asdescribed herein. These methods of creating an anatomical configurationmay utilize special tools that are further described herein.

As mentioned previously, the surgical repair of dislocated joints tendsto be invasive and is commonly done in an “open” surgical setting,requiring a relatively large incision and extensive tissue retraction.When used in combination with enabling surgical tools, disclosed herein,a minimally invasive, arthroscopically assisted, or even arthroscopicapproach may be used for implantation of a prosthetic band.

Disclosed herein, is a passing instrument that allows the surgeon topass a prosthesis or a passing suture around the deeper-lying bones. Itis also useful for passing elements around more superficial bones inthat it may require less soft tissue dissection and retraction. Thispassing instrument is particularly useful for facilitating the passageof a prosthetic band of the type disclosed with this application.

In embodiments, an elongated cannula of the passing instrument is placedadjacent the bone to be circumvented. A shape memory element (wire orribbon) that has been preformed to a diameter similar to or smaller thanthe bone diameter is disposed in the lumen of the cannula. Inside thelumen of the cannula, the shape memory element is constrained into agenerally straight configuration. The cannula is fixedly attached to ahandle of the passing instrument that houses a structure for extendingand retracting the shape memory element out the distal cannula tip. Apassing suture construct is detachably affixed to the distal tip of theshape memory element and also to the extension/retraction element. Whenthe shape memory element is extended with the cannula adjacent the boneto be circumvented, the shape memory element encircles the bone,carrying the passing suture construct along with it. The distal end ofthe passing suture construct may then be picked up on the other side ofthe bone using standard surgical instruments. The shape memory elementis then retracted within the lumen so that the cannula may be safelyremoved from the body. In embodiments, the cannula may have one or morefeatures that facilitate proper placement of the cannula alongside thebone. For example, a protrusion can be provided that engages a bone foralignment. Various embodiments of the distal shape memory element tipand passing suture configurations are disclosed.

In embodiments, the proximal or handle portion of the passing instrumentmay be configured as a pistol-grip. The mechanism inside the handleportion may be configured so as to push the shape memory element out ofthe distal tip of the cannula at varying increments. A return trigger isdisclosed that is attached to the extending/retracting element at theproximal end of the shape memory element. This return trigger allows theuser to retract the shape memory element back into the cannula and maybe attached to a suture-anchoring element provided through a slot in thehandle housing. In an embodiment, the suture-anchoring element is aspool around which the passing suture element may be wrapped. A sutureretention feature may be disposed on the anchoring element and isdesigned to pinch or otherwise firmly but releasably grip the passingsuture element.

It may be beneficial for the shape memory element to deliver the passingsuture construct all the way around the bone and reattach it to thecannula or a suture-receiving feature thereon. Disclosed within thisapplication are various embodiments of passing suture reconnectingconfigurations. A soft sock-like structure that forms a tight-fittingcap over the distal tip of the shape memory element is disclosed in oneembodiment. The passing suture construct is threaded through the capthat, after circumventing the bone, is trapped and retained by mechanismon the cannula. Other embodiments of suture passing/grabbing mechanismsinclude magnets and/or hooks to accomplish the suture pass back to thecannula. Once the suture has circumvented the bone and is reattached tothe cannula, the cannula may be retrieved with both ends of the passingsuture construct intact, thus saving the surgeon time and effort.

In embodiments, the aforementioned passing suture construct can beplaced partially or fully around the circumference of the bone. Thispassing suture construct can be used to pull the prosthetic band intoplace around/under/behind a given bone, and thus is not a suture in thetraditional sense. It does not remain in the body as a permanent implantor perform any ongoing function such as holding tissue together. Thepassing suture construct can be a single suture strand with a small loopon each end. The loops at each end facilitate temporary attachment tothe shape memory element and the extension/retraction mechanism as wellas ultimately the prosthetic band. In other embodiments, the passingsuture construct is one continuous loop of suture or a single strandwith knots at one or both ends. Features to aid in retrieval may also beemployed such as tabs, or shorter trailing suture strands.

In embodiments, various methods of supporting or stabilizing joints aredisclosed. These various methods may include various configurations ofthe prosthetic band around the bony structures. For example, a singleloop of the prosthetic band around two adjacent but separated bones isdisclosed for stabilizing the joint and/or providing support to theinjured ligaments. Other embodiments include a “Figure 8 configuration”,and a “Double-Luggage-Tag” configuration, which involves two loopsaround the clavicle at distinct, separated points, and two loops aroundthe clavicle at the same location.

In embodiments, a method of stabilizing the AC joint is disclosed. Themethod includes: 1.) inserting a shape memory passing device into thejoint space and adjacent the coracoid; 2.) using the passing device,extending a shape memory element with a passing suture attached at leastpartially around the coracoid; 3.) retrieving the passing suture fromthe tip of the shape memory element and bringing the passing sutureoutside the joint space; 4.) using the passing suture construct to pulla prosthetic band into position around the coracoid and the clavicle;and 5.) fixedly attaching the two ends of the prosthetic band in atensioned state so as to reduce the separation of the coracoid and theclavicle.

In other embodiments, methods for placing a passing suture elementaround a bone are disclosed. These methods include: 1.) insertion of apassing device into the joint space and adjacent the coracoid; 2.)incrementally extending a shape memory element at least partially aroundthe coracoid, said shape memory element carrying a passing sutureconstruct; 3.) detaching the proximal end of the passing sutureconstruct from the shape memory element; 4.) retrieving the passingsuture construct from generally the other side of the bone; and 5.)retracting the shape memory element back into the passing device.

For a more comprehensive understanding of the nature and advantages ofthe present invention, reference should be made to the ensuing detaileddescription and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prosthetic band assembly with abuckle-type connector in accordance with embodiments.

FIG. 2 is a perspective view of a dislocation acromioclavicular (AC)joint of a human body.

FIG. 3 is a perspective view of an open prosthetic band placed in the ACjoint in accordance with embodiments.

FIG. 4 is a perspective view of a prosthetic band in place and securedaround the coracoids and clavicle bones in accordance with embodiments.

FIG. 5 is a perspective view of an alternate configuration of theprosthetic band in a “Figure 8” around the bones in accordance withembodiments.

FIG. 6 is a perspective view of an alternate configuration of aprosthetic band in an anatomical configuration around the bones inaccordance with embodiments.

FIG. 7 is a perspective view of an alternate configuration of aprosthetic band in an anatomical configuration around the bonesincluding the acromium in accordance with embodiments.

FIG. 8a is a perspective view of an open prosthetic band assembly havinga hook and loop closure in accordance with embodiments.

FIG. 8b is a perspective view of the prosthetic band assembly of FIG. 8asecured in place around the coracoids and clavicle.

FIG. 9a is a perspective view of an a cable tie type prosthetic bandassembly in accordance with embodiments.

FIG. 9b is a perspective view of a cable tie type prosthetic band inplace around the coracoids and clavicle in accordance with embodiments.

FIG. 10a is a perspective view of a custom-shaped anatomical prosthesisfor AC joint stabilization in accordance with embodiments.

FIG. 10b is a perspective view of a custom-shaped anatomical prosthesisfor an AC joint secured in place around the clavicle and coracoid inaccordance with embodiments.

FIG. 11a is a perspective view of an alternative embodiment of ananatomical prosthesis for AC joint stabilization.

FIG. 11b is a perspective view of an alternative embodiment of ananatomical prosthesis for AC joint stabilization in place around thecoracoid and clavicle of a human.

FIG. 12a is a perspective view of a plate-like connector in accordancewith embodiments.

FIG. 12b is a perspective view of a prosthetic band assembly with theplate-type connector of FIG. 12a in place around the clavicle andcoracoid of a human in accordance with embodiments.

FIG. 13 is a perspective view of a prosthetic band assembly with aplate-type connector in place around the clavicle and coracoid with atendon graft attached in accordance with embodiments.

FIG. 14 is a perspective view of a prosthetic band assembly with aplate-type connector having self-locating flanges in accordance withembodiments.

FIG. 15 is a perspective view of a prosthetic band assembly with a softplate connector and a figure 8 band configuration in accordance withembodiments.

FIG. 16 is an embodiment of prosthetic band connector with a deflectablecleat locking mechanism in accordance with embodiments.

FIG. 17 is a section view of an embodiment of a prosthetic bandconnector with a deflectable cleat locking mechanism and the prostheticband shown in place in accordance with embodiments.

FIG. 18 is another section view of an embodiment of prosthetic bandconnector with a deflectable cleat locking mechanism and the prostheticband shown in place, shown with the cleat deflected in the lockedposition.

FIG. 19 is a perspective view of an embodiment of prosthetic bandconnector with a deflectable cleat locking mechanism configured toaccept a screw for fixation to a bone.

FIG. 20 is a perspective view of an embodiment of prosthetic bandconnector with a deflectable cleat locking mechanism configured withprotrusion on the bottom surface for fixation to bone.

FIG. 21 is a perspective view of an embodiment of prosthetic bandconnector with a deflectable cleat locking mechanism configured with thecleat in the lateral position in accordance with embodiments.

FIG. 22 is a perspective view an embodiment of prosthetic band connectorwith two deflectable cleat locking mechanisms in accordance withembodiments.

FIG. 23 is a perspective view an embodiment of a buckle-type prostheticband connector with a prong retention mechanism in accordance withembodiments.

FIG. 24 is a perspective view an embodiment of a buckle-type prostheticband connector with a prong retention mechanism shown deflected in alocked position in accordance with embodiments.

FIG. 25 is a perspective view an embodiment of a buckle-type prostheticband connector with an alternative deflectable locking mechanism inaccordance with embodiments.

FIG. 26 is a perspective view an embodiment of prosthetic band connectorthat is configured as a crush tube in accordance with embodiments.

FIG. 27 is a perspective view of an embodiment of prosthetic bandconnector with a pivoting wedge arm locking mechanism showing theprosthetic band in place in accordance with embodiments.

FIG. 28 is a section view of an embodiment of prosthetic band connectorwith a pivoting wedge arm locking mechanism showing the prosthetic bandin place in accordance with embodiments.

FIG. 29 is a section view of an embodiment of prosthetic band connectorwith a pivoting wedge arm locking mechanism showing the prosthetic bandin place compressed by the wedge arm.

FIG. 30 is a perspective view an embodiment of prosthetic band connectorwith a double clamping mechanism in accordance with embodiments.

FIG. 31 is a section view an embodiment of prosthetic band connectorwith a double clamping mechanism shown with the prosthetic band in placein accordance with embodiments.

FIG. 32 is a section view an embodiment of prosthetic band connectorwith a double clamping mechanism shown with the prosthetic bandcompressed by the clamping mechanism in accordance with embodiments.

FIG. 33 is a perspective view an embodiment of prosthetic band connectorwith a pivoting cam arm retention mechanism in accordance withembodiments.

FIG. 34 is a section view an embodiment of the prosthetic band connectorof FIG. 33 with a pivoting cam arm retention mechanism with the arm up.

FIG. 35 is a section view an embodiment of the prosthetic band connectorof FIGS. 33 and 34, with the pivoting cam arm retention mechanism havingthe arm down in the locked position.

FIG. 36 is a perspective view an embodiment of prosthetic band connectorwith suture passing slots in accordance with embodiments.

FIG. 37 is a section view of an embodiment of the prosthetic bandconnector of FIG. 36 with sutures in place to provide retention of theband in accordance with embodiments.

FIG. 38 is a perspective view an embodiment of a prosthetic bandconnector with alternating deflection tabs in accordance withembodiments.

FIG. 39 is a perspective view of an embodiment of a prosthetic bandconnector with a toothed arm clamping mechanism in accordance withembodiments.

FIG. 40 is a section view of the prosthetic band connector of FIG. 39.

FIG. 41 is a schematic illustration showing the bones of the shoulderjoint with a passing instrument inserted therein, in accordance withembodiments inserted.

FIG. 42 is a schematic illustration showing the bones of the shoulderjoint with the passing instrument of FIG. 41, with a shape memoryelement of the passing instrument further extended.

FIG. 43 is a schematic illustration showing the bones of the shoulderjoint with the passing instrument of FIGS. 41 and 42, with a surgicalgrasper receiving a passing element from the passing instrument.

FIG. 44 is a schematic illustration, in furtherance to FIG. 43, showingthe passing element pulled through the bones of the shoulder joint inaccordance with embodiments.

FIG. 45 is a schematic illustration, in furtherance to FIG. 44, showingthe bones of the shoulder joint with a prosthetic band partially inplace.

FIG. 46 is a schematic illustration showing the bones of the shoulderjoint with a passing instrument partially deployed around the clavicle.

FIG. 47 is a perspective view an embodiment of a passing instrument witha passing element installed in accordance with embodiments.

FIG. 48 is a perspective, cut-away view of the passing instrument ofFIG. 47.

FIG. 49 is an exploded view of the passing instrument of FIG. 47.

FIG. 50 is a perspective view of an embodiment of a distal cannula witha bone-locating protrusion accordance with embodiments.

FIG. 51 is a perspective view of an embodiment of a distal cannula witha bone-locating protrusion and curvature in accordance with embodiments.

FIG. 52 is a perspective view of an embodiment of a distal cannula witha bone-locating prong in accordance with embodiments.

FIG. 53 is a perspective view of an embodiment of a distal cannula witha passing element control feature in accordance with embodiments.

FIG. 54 is a perspective view of an alternate embodiment of a distalcannula with a passing element control feature.

FIG. 55 is a perspective view of another embodiment of a distal cannulawith a passing element control feature.

FIG. 56 is a perspective view of a shape memory element in accordancewith the embodiments.

FIG. 57 is a side view of the shape memory element of FIG. 56.

FIG. 58 is a profile view of the tip of the shape memory element ofFIGS. 56 and 57 in accordance with the embodiments.

FIG. 59 is a perspective view of the tip of a shape memory element witha passing element installed in accordance with the embodiments.

FIG. 60 is a perspective view of another embodiment of a tip of a shapememory element with a passing element installed.

FIG. 61 is a perspective view of yet another embodiment of a tip of ashape memory element with a passing element installed.

FIG. 62 is a perspective view of a passing element in accordance withthe embodiments.

FIG. 63 is a perspective view of a another embodiment of a passingelement.

FIG. 64 is a perspective view of yet a another embodiment of a passingelement.

FIG. 65 is a perspective view of still yet another embodiment of apassing element.

FIG. 66 is a perspective view of a passing cap with a passing element inaccordance with embodiments.

FIG. 67 is a perspective view of another embodiment of a passing capwith a passing element.

FIG. 68 is a schematic illustration of a passing instrument with asuture-receiving feature in place around a bone in accordance withembodiments.

FIG. 69 is a schematic illustration, in furtherance to FIG. 68, of thepassing instrument with the suture-receiving feature, with a passingelement attached to the suture-receiving feature.

FIG. 70 is a schematic illustration of another embodiment of a passinginstrument with a suture-receiving feature in place around a bone.

FIG. 71 is a schematic illustration of a passing instrument with asuture-receiving feature of FIG. 70, with a passing element attached tothe suture-receiving feature.

FIG. 72 is a section view of an embodiment of a prosthetic band systemin place near the tibiofibular junction in accordance with theembodiments.

FIG. 73 is a schematic illustration of a prosthetic band with connectorin place around the coracoid and clavicle of a shoulder with an AC jointdislocation and a counter traction tool being aligned.

FIG. 74 is a schematic illustration, in furtherance to FIG. 73, of acounter traction tool in use to reduce the dislocation.

FIG. 75 is a schematic illustration of a punch being aligned to deflectthe cleat of a prosthetic band connector.

FIG. 76 is a schematic illustration, in furtherance to FIG. 75, of thepunch tool having deflected the cleat of the prosthetic band connector.

FIG. 77 is a schematic view of a prosthetic band and connectorconfigured to span a acromioclavicular joint.

FIG. 78 is a schematic view of an embodiment of an AC joint repairsystem designed to span the acromioclavicular joint using suture.

FIG. 79 is a schematic view of a tendon graft with a tip attachment.

FIG. 80 is a schematic view of a tendon graft with a tip attachmentinserted through a connector.

FIG. 81 is a schematic view of a tendon graft with connector showingtendon graft in temporary locked mode.

FIG. 82 is a schematic view of a tendon graft with connector showingtendon graft in permanent lock mode.

FIG. 83 is a schematic view of a passing device circumventing a femurbone.

FIG. 84 is a schematic view in furtherance to FIG. 83 showing a shuttleplaced around the femur with cerclage cable attached.

FIG. 85 is a schematic view in continuance if FIG. 84 showing thecerclage cable further pulled around a femur bone.

FIG. 86 is a perspective view of an embodiments of a cerclage tipdesigned to accommodate a shuttle loop.

FIG. 87 is a perspective view of another embodiment of a cerclage tipdesigned to accommodate a shuttle loop.

FIG. 88 is a perspective view of a fracture plate and prosthetic bandsystem for repairing long bone fractures.

DETAILED DESCRIPTION

In the following description, various embodiments of the presentinvention will be described. For purposes of explanation, specificconfigurations and details are set forth in order to provide a thoroughunderstanding of the embodiments. However, it will also be apparent toone skilled in the art that the present invention may be practicedwithout the specific details. Furthermore, well-known features may beomitted or simplified in order not to obscure the embodiment beingdescribed.

The technology disclosed herein has a broad application in orthopedicsurgery. Procedures supported by devices disclosed herein include:Acromioclavicular joint stabilization/repair; tibiofibular syndesmosisstabilization/repair; other orthopedic procedures wherein an injuredjoint requires stabilization or repair; or any situation where two bonesare separated and require reduction.

Embodiments proposed herein are directed to a flexible band-likeprosthesis, referred to as “prosthetic band,” for stabilizing bones inproper position. After the prosthetic band is in place, a connector isused to join the two ends of the prosthetic band around the bones. Oneend of the prosthetic band can be permanently attached to the connector,with the other attachable to the connector, or both ends can beattachable.

For example FIG. 1 is a perspective view of a prosthetic band assembly100 with a wide flexible prosthetic band 102 and a connector mechanism106. The band is significantly wider than a typical orthopedic suturestrand or even suture tape (which is about 2 mm wide), and is typically4 mm wide or wider. This extra width serves to distribute the loads seenby the band over a greater area of bone surface, thus reducing the riskof sawing into the bone due to repetitive motion. In the embodimentshown in the drawings, a proximal end 108 of the prosthetic bandassembly passes through a slot 110 of the connector mechanism 106 and isfixedly attached back to the main loop of the prosthetic band by sewing,heat-staking or some other permanent attachment means. To connect adistal end 116 of the prosthetic band 102 to the connector mechanism106, the distal end of the prosthetic band is threaded through areceiving slot 112 in the superior aspect of the connector and placedunder a locking cleat 104. The locking cleat 104 protrudes from one sideof the connector and extends over a locking slot 114, which may be athrough slot or a blind slot, and which only extends through part of thetotal thickness of the connector. In its neutral or unactivated state,the locking cleat 104 extends roughly parallel to, or at a slight upwardangle to, the superior surface of the connector and approximately acrossthe full extent of the locking slot, and to the far end of the lockingslot. This allows insertion of the distal end 116 of the prosthetic bandunder the locking cleat. When the distal end 116 of the prosthetic bandis fed through the receiving slot 112, inferior to superior, and placedunder the locking cleat in the unactivated or neutral state, temporaryfixation is achieved.

To install the prosthetic band 102, the distal end 116 is extendedthrough the receiving slot 112, and looped under the locking cleat 104.The relationship of the locking cleat and the leading and trailing edgesof the locking slot 112 are such that the prosthetic band 102 isfrictionally engaged by its serpentine path through the receiving slot112, over the top of the connector 106, down into the locking slot 112,under the locking cleat 104, and back into engagement with the lockingcleat and the top portion of the connector. The temporary fixation isachieved by friction at points of engagement of the prosthetic band 102at these locations. Further information about this relationship isdescribed with reference to FIGS. 16-18, where a similar buckle isdescribed.

Temporary fixation generally requires a holding force on the prostheticband greater than the force required to reduce the two bones beingstabilized, which is generally associated with the weight of thepatient's arm. This temporarily fixated state allows the surgeon toassess the positioning of the bones, possibly with x-ray or othervisualization methods, to determine if reduction and positioning areadequate. If greater or less reduction or repositioning is required, theprosthetic band 102 may be readily removed from under the locking cleat104 for further/less tensioning, etc. This process can be done in aniterative manner until proper tensioning of the prosthetic band assembly100 is achieved.

Once the appropriate position of the prosthetic band assembly 100 andassociated bones are achieved, the prosthetic band 102 may be placedinto a more permanently fixed state within the connector 106 bypermanently bending the locking cleat 104 downward with another surgicaltool such as an orthopedic punch. This bending of the locking cleat 104prevents further movement of the prosthetic band 102 relative to theconnector 106, and fixes the loop formed by the prosthetic band assembly100 to a fixed length.

To bend the locking cleat 104 down, an automatic center punch (notshown) can be used. An automatic center punch is a hand tool that istypically used to produce a dimple in a workpiece (for example, a pieceof metal). It performs the same function as an ordinary center punch butwithout the need for a hammer. When pressed against the workpiece, itstores energy in a spring, eventually releasing the energy as an impulsethat drives the punch, producing the dimple. The impulse provided to thepoint of the punch is quite repeatable, allowing for uniform impressionsto be made. When used with the connector 106, the tip of the automaticcenter punch can be aligned with an indentation 118 on the locking cleat104, and the automatic center punch can be pushed downward, storingenergy into the spring until eventually firing the punch, which drivesdown, bends, and locks the locking cleat 104 into place. Thus, whenpressed downward against the locking cleat 104 to a certain force level,the automatic center punch activates the spring mechanism which enhancesthe downward force to deflect the cleat. An automatic center punchtypically makes an audible sound, indicating that the spring has beenactivated and thus may provide audible feedback to the surgeon that thelocking cleat has been deflected to fix the prosthetic band in place.The spring release can typically be felt too, providing tactilefeedback. Other lock-activation mechanisms may be used, with or withoutaudible or other signals indicating activation. When the connector isplaced in the locked or fixed position, the resulting construct(connector plus prosthetic band) may generally have an ultimate failureload equal to or greater than the native ligaments that are beingaugmented. In addition, the prosthetic band 102 is locked in placerelative to the connector 106, assuring no further movement of the tworelative to each other. The prosthetic band assembly 100 can then besewn into the body through healing. Additional connector embodiments aredisclosed later in the application.

FIG. 2 shows a human shoulder joint that has a “separated shoulder” asdescribed earlier in this application. The acromioclavicular ligaments180 and the coracolclavicular ligaments 182 are severely disrupted. Theclavicle bone 184 is shown displaced from both the coracoid bone 186 andthe acromium 188. FIG. 2 represents an extreme case of this type ofinjury and is intended to show the bone displacement for simplicity andclarity. Most injuries don't involve complete severing of the ligamentsas shown, but generally some level of damage one or both of the sets ofligaments shown. When damaged, these ligaments may stretch and becomedislocated, and thus have a similar effect of allowing the clavicle boneto become displaced from the coracoid and or acromium. When surgicallyrepairing a separated shoulder, augmentation of one of both of theligamentous joints can effectively reduce the separation. For sake ofsimplicity and clarity, one or both sets of ligaments may not be shownin subsequent figures.

FIG. 3 shows an AC joint complex with a clavicle bone 120 displacedsuperiorly from the acromium 122 and the coracoid 124. A prosthetic band126 (e.g., such as the prosthetic band 102) with a connector 128 (e.g.,such as the connector 106) pre-attached to one end is shown looped underthe coracoid and the distal, free end 130 of the prosthetic band on theopposite side of the clavicle from the connector. When the free end 130of the prosthetic band 126 is threaded through the connector 128 andpulled or cinched as shown in FIG. 4, to create a taut loop, theclavicle bone is reduced back to a more natural position. In thissimplified example, the prosthetic band 126 is serving as a proxy forthe injured coracoclavicular ligaments (not shown), while also allowingthe acromioclavicular ligaments 132 to heal in a more natural position.This is the most basic structural configuration of a prosthetic bandassembly disclosed herein. Other configurations may be created using asingle prosthetic band with connector, and many of those configurationsare described herein.

FIG. 5 shows another configuration of a single prosthetic band withconnector. The prosthetic band 134 (e.g., similar to the prosthetic band102) is crossed over itself above the coracoid resulting in the loopreaching from the anterior side of the coracoid to the posterior side ofthe clavicle with the other leg doing the opposite. This type ofconfiguration may result in better stabilization of the joint and allowless movement of the bones, particularly in the anterior-posteriordirection.

FIG. 6 shows another configuration of a single prosthetic band withconnector. In this “Double-Luggage-Tag” configuration, the singleprosthetic band 140 (e.g., similar to the prosthetic band 102 butlonger) is looped twice under the coracoid and around the clavicle. Assuch, two loops extend around the clavicle. In embodiments, the twoloops are separated from each other by a particular separation 142, forexample about 20 mm. As stated above, the prosthetic band also loopstwice under the coracoid, but these two loops can be at essentially thesame point 144 or adjacent one another. This configuration mimics thenatural positioning of the coracoclavicular ligaments and may beconsidered an “anatomical repair” as known in the medical community.

FIG. 7 shows yet another configuration of a single prosthetic band withconnector. In this configuration, the single prosthetic band 150 (e.g.,similar to the prosthetic band 102 but longer) loops under the coracoid156 and is threaded through two clavicular bone tunnels 152, usuallyabout 20 mm apart, and across to loop around the acromium 154. The twoclavicular bone tunnels 152 are drilled by a surgeon during theinstallation process. This configuration mimics the natural positioningof the coracoclavicular ligaments as well as the acromioclavicularligaments, and may be considered an “anatomical repair” as known in themedical community.

The embodiments of prosthetic bands disclosed thus far are flexibleconstructs fabricated from medical grade materials suitable forimplantation in the body. In an embodiment, the prosthetic band is awoven polyester (PET) construct, however the prosthetic band could alsobe constructed by braiding from a variety of other suitable flexiblebiomaterials such as Ultra High Molecular Weight Polyethylene (UHMWPE)or blends or suitable materials. In embodiments, the prosthetic band iswoven with metallic yarns such as stainless steel or nitinol. Variousprocesses may be applied to the woven or braided band constructs toprovide better performance characteristics. For example, heat treatmentof band material after braiding can reduce the propensity of the weaveto fray. Lack of fraying is particularly important to the“adjustability” aspect of the invention. After placing a prosthetic bandand tightening it to reduce the bone dislocation, a surgeon may need totrim the excess material of the prosthetic band. Fraying at the point oftrimming may reduce the effectiveness of the device.

In embodiments, other prosthetic band materials and other connectionmechanisms may be employed. FIG. 8a shows a single loop prosthetic band160 of a similar woven construct as previously disclosed. Thesimplified, pre-attached connector 162, however does not have anintegrated locking feature as previously disclosed. Rather, ahook-and-loop connection mechanism is utilized. The distal end of theprosthetic band 164 is disposed with loop portion of the hook-and-loopconnector while the hook portion 166 is strategically placed along aportion of the band. After looping the bones and threading the distaltip of the band through the connector slot, it is doubled-back over andattached to the hook portion on the band to form a permanent connectionas shown in FIG. 8b . The hook and loop connectors can provide bothtemporary and permanent fixation of the prosthetic band.

In accordance with additional embodiments, a single band prosthesis maybe provided with an integrated connector. For example, FIG. 9a shows asingle band prosthesis 161 configured similar to a cable-tie device. Theprosthetic band has an integrated connecter 163 at the proximal end anda distal tip 162 configured with notches, fenestrations, bumps, grooves,teeth or other features so as to catch on a lock arm within theintegrated connector on the proximal end. When placed in the AC joint asshown in FIG. 9b , the device may be tightened by pulling the distal endthrough the connector until the desired reduction is achieved. Anintegrated lock arm in the proximal connector can be provided to preventthe distal portion from sliding backward and loosening. This embodimentcan be tightened further, but typically cannot be loosened onceinstalled, so the temporary fixation features described above areprovided only to the extent that further tightening of the single bandprosthesis 161 is desired.

Ligament prostheses other than the single-band variety as discussed thusfar are disclosed herein. In an effort to create an anatomical repair asdefined previously, a specially-shaped prosthesis is proposed whichinherently results in an “anatomic” configuration when implanted. FIG.10a shows a generally X-shaped prosthesis 170 with a somewhat elongatedcenter section 172. When placed in the joint space to stabilize the ACjoint, the center section 172 is situated under the coracoid 174 withthe two legs 176 of one side of the “X” joining over the top of theclavicle with the two legs from the other side of the “X”. Connectors179 as described elsewhere herein may be used to secure thecorresponding legs to one another. The resulting configuration as shownin FIG. 10b represents a desirable “anatomic” configuration.

In another embodiment of an anatomically configured prosthesis 180, an“X” shape is created from multiple components. FIG. 11a show a generally“X” shaped prosthesis fabricated from two individual bands 186 and 188connected where they cross at the center with a generally rectangularcenter piece 182. The rectangular center piece 182 maybe be a flatflexible woven or braided component or alternatively a tubular weave orbraid. The flat variety would have the legs 186 and 188 fixed to oneside by sewing, heat-staking, gluing or other construction technique orpossible threaded through the yarns of the braided or woven centerpiece. Alternatively, the tubular center piece could allow theindividual legs 186 and 188 to slide freely through lumen of the centerpiece. The legs may be anchored with connectors as described herein.When implanted in a joint as shown in FIG. 11b , one leg 186 starts atthe anterior portion of the clavicle and loops under the coracoid 184,crosses the other leg 188 at the center piece and loops under theclavicle to the posterior part of the clavicle. The leg 186 would thenconnect to the other leg 188 via a connector 189 on the superior portionof the clavicle.

Thus far the connectors described for joining the ends of the prostheticbands have been small devices appropriate for connecting two ends of thesame band together at a single point or two ends of two bands togetherat a single point. Further connector embodiments include a somewhatlarger plate-type connector that is capable of connecting single ormultiple bands at the same point or at two distinct, separate points. Inkeeping with the “anatomic” theme, it may be desirable to have the twoconnection points separated by about 20 mm in order to mimic the nativeligaments. The larger plate-type connector may also be conducive to thedrilling of clavicular bone tunnels so as to allow the placement of atendon graft. With clavicular bone tunnels being known to possiblyweaken the clavicle, potentially resulting in fracture, the platestructure may provide support to the bone and/or act as a strain reliefagainst the forces generated by the prosthesis and/or tendon graft.Ideally, a single loop prosthesis would share loading forces with thetendon graft that is placed through clavicular and plate-connectorholes.

For example, FIG. 12a shows an embodiment of a plate-type connector 192with receiving slots 185 near the center and a locking cleat 181 betweenthe slots. Holes 183 are configured at the distal ends of the plate foruse with tendon grafts if desired. The plate-type connector 192 can beconnected to the bone, for example by screws, adhesive or anothersuitable connector or connection structure. In this manner, theplate-type connector 192 can serve as a bone plate, stabilizing afracture or preventing a fracture when bone tunnels are added. FIG. 12bshows the embodiment of FIG. 12a wherein two ends of a prosthetic band187 are both attached to the plate near the center of the plate. One ofthe ends may be pre-attached during manufacturing with the other endbeing attached during surgery. The second attachment point may be thecleat locking mechanism described earlier, with both temporary andpermanent locking modes. Alternatively the second attachment point maybe an attachment of any of the other attachment means, including, butnot limited to, those disclosed herein.

The two holes at either end of the plate-type connector are positionedabout 20 mm apart so as to provide an anatomic configuration when atendon graft 190 is used as shown in FIG. 13. The tendon graft 190 loopsunder the coracoid and the two ends are threaded through the clavicularbone tunnels and as well as through the plate. The tendon graft 190 maythen be secured by tying it to itself with knots or suture, orinterference screws may be used.

FIG. 14 shows an embodiment of a prosthetic band 204 with an alternateembodiment of a plate-type connector 200. This connector 200 includesflanges 202 at either end that protrude inferiorly over the sides of theclavicle to maintain proper placement on top of the clavicle. Inembodiments, the flanges may be beveled or sharpened so as to penetrateinto any soft tissue around the clavicle. The attached prosthetic band204 is fixedly pre-attached through a slot 206 on one end of theplate-type connector with the other end of the band attached duringsurgery through slots 208 at the opposing end of the plate. Thisattachment at the opposing end of the plate-type connector 200 may be ofthe type disclosed in FIG. 1 or any other connector mechanism disclosedherein. Alternatively, the prosthetic band 204 may be placedindependently, not pre-attached to the connector then attached duringthe surgical procedure by any of the attachment means disclosed herein.

FIG. 15 shows an embodiment of a prosthetic band assembly with a softplate-type connector 210. The plate-type connector of this embodiment isfabricated from woven, braided or molded biomaterials such as but notlimited to PET or UHMWPE or nylon or like thermoplastics. Slots 212 ineach end of the soft plate structure receive the free ends of theprosthetic bands 214 where the free ends may be sewn to the plate orattached via some other means. In embodiments, small metal or plasticconnectors may be integrated into the soft plate during manufacturing toreceive and lock the prosthetic bands into place. The two prostheticbands 214 of the shown embodiment each cross over the coracoid to form afigure 8 before connecting on the plate at the superior aspect of theclavicle.

Returning now to the buckle-type connectors, FIG. 16 shows an embodimentof a connector 240 that is similar to the buckle-type connector ofFIG. 1. As previously described, this type of one-piece connector hasadvantages in that it is simple in design, low in cost to manufacture,and easy to use. It also has both temporary and permanent prostheticband retention capability. This embodiment of the connector 240 has anopen locking slot 242, whereas the locking slot of FIG. 1 was a blindslot in that it did not go all the way through the connector. As in FIG.1, this embodiment has an angled receiving slot 244 and a straight slot246 where a prosthetic band may be fixedly attached. The locking cleat247 has small dimple 248 that is intended to receive the tip of a manualor automatic center punch which is used to deflect the cleat downwardinto the locked position.

FIG. 17 is a section view of the connector 240 of FIG. 16 with aprosthetic band 252 affixed. The prosthetic band 252 is shown fixedlyattached at a proximal end through the straight slot 246. On the otherend of the connector, the distal or free end 254 of the band 252 is fedthrough the angled receiving slot 244 then under the locking cleat 247.This represents the temporarily locked state, which is temporarilylocked and unlocked as described above with respect to FIG. 1. Asdescribed with that embodiment, the band 252 may be removed from underthe cleat 247 to unlock the band, tighten or loosen the band around thebones, and reset the band in the cleat to adjust the size of the loopmade by the band and/or the tension applied by the loop. The temporarylocking is achieved through the friction generated by the angled slot.Because of the angle it must navigate, the prosthetic band is preventedfrom sliding due to the friction on the edges 250 of the slot. Thebottom surface of the cleat itself also provides some friction, as wellas the band's engagement with the locking cleat, as described withreference to the embodiment of FIG. 1, above.

In FIG. 18, the locking cleat 247 is show deflected into a downwardposition into the locking slot. In doing so, the prosthetic band is alsoforced downward into the locking slot, thus pinching the band andcreating more corners with additional friction that must be overcome tounlock. This provides more permanent or irreversible fixation/retention.Any number of orthopedic tools may be used to deflect the cleat such aspunches, clamps, needle drivers, etc. In an embodiment, as describedabove, an automatic center punch provide a repeatable deflection for toachieve the fixation. Use of such a punch further provides an audibleand perhaps tactile indication to the surgeon that the cleat has beendeflected. The dimple 248 may be used to align the automatic centerpunch with the locking cleat 247.

It is important to note that this embodiment as well as all otherconnector embodiments disclosed herein provides the capability ofadjustment to the band tension around the bones. By feeding the bandthrough a receiving slot on the connector and pulling the free end ofthe band while providing countertraction to the connector, band tensionis increased. By virtue of the friction generated by both the receivingslot and the cleat, temporary fixation/retention is achieved. Thisallows the surgeon to assess the bone reduction, possibly by means suchas x-ray, while the prosthetic band remains temporarily fixed. Temporaryfixation of this nature must hold a force at least equivalent to theforce required to reduce the bones (typically between 10 and 100 N). Ifadditional adjustments are required, the prosthetic band is moved fromunder the cleat, allowing the band to slide within the receiving slot.Additionally, more permanent retention/fixation is provided by theconnector (in this embodiment, by deflecting the cleat downward). Thisfixation would benefit from a holding force equivalent to or greaterthan the strength of the native ligaments being augmented, which isgenerally in the range of 450 N to 750 N.

Other buckle-type connector embodiments that provide the functions andbenefits described above are disclosed. Referring back to the generalbuckle configuration of FIG. 16, additional features to this embodimentmay be beneficial.

FIG. 19 shows a buckle-type connector 256 similar to that of FIG. 16,with the addition of a feature in the form of a hole 260 allowing forthe insertion of a small monocortical screw 258 or pin, which wouldanchor the connector to a surface such as the clavicle bone. Generally,the connector would be held in its relative position by the soft tissuesurrounding the bones, however it may be beneficial prevent any movementof the connector in any direction. Said hole may be tapered orcountersunk so as to allow the screw head to sit flush with the surfaceof the plate. A pilot hole may be drilled into the bone prior toinsertion. In embodiments, connectors disclosed herein may be configuredso as to accept one or multiple screw-type or other anchor retentionmechanisms.

In FIG. 20, tapered protrusions 262 are shown configured on the bottomsurface of a buckle-type connector 264. The protrusions 262 may beconfigured so as to penetrate the bone surface and prevent movement ofthe connector along the surface of the bone. The protrusions 262 mayalternatively be configured, such as in low profile or high frictionarrangements, so as to provide resistance to movement withoutpenetration of the surface. In embodiments, one or more protrusions maybe present. In other embodiments, undulations, corrugations, pits,grooves, knurling or other surface-disrupting features may be present onthe bottom of the connector to provide resistant to movement.

In FIG. 21, another embodiment is shown of a buckle-type connector witha cleat. This embodiment is similar to the embodiment of FIG. 16, butwith the cleat 266 and locking slot 268 moved to the end of theconnector and the receiving slot 270 moved to the center. This connectorembodiment provides all the same functions and advantages of theprevious embodiment but with the locking cleat 266 on the end of thepart, the direction of pull of the band through the receiving slot 270at the center is toward the part end rather than the center. Given thesurgical situation, this may provide a more convenient action forlocking.

FIG. 22 is another embodiment of a buckle-type connector with twolocking cleats. This connector embodiment provides all the samefunctions and advantages of the previous embodiment but does not havethe prosthetic band pre-attached to one end. In order to achieve certainanatomical repair configurations with the prosthetic band, such as thatof FIG. 6, it may be necessary to pull both ends of the prosthesis underthe coracoid bone. This may be difficult to achieve with the connectorpre-attached due to the friction caused by the surrounding soft tissue.

Therefore, the two free ends 272 of the prosthetic band may be passedand the connector assembled once the prosthesis is in position. The twofree ends of the prosthesis are fed through the two receiving slots 274near the center of the connector. One of the cleats is then deflected asdescribed previously to lock the band in place. The other end of theband may then be used to adjust and/or tension the band construct inorder to achieve appropriate bone reduction. Once achieved, the secondcleat may be deflected to permanently fix the construct in place. Thisembodiment shows a curved bottom surface 276 of the connector to betterapproximate the shape of the bone. Alternatively, the entire connectormay be curved to a degree that better matches the bone surface.

FIG. 23 is an embodiment of a simplified buckle-type connector. As withprior embodiments, a prosthetic band may be fixedly attached to one end278 of the connector by sewing, gluing, heat staking or other assemblytechnique. The free end of the prosthetic band, after encircling thebones to be stabilized or reduced is fed up through the next availableslot 280 then fed down through the adjacent slot 282 and finallyreturning up and out of the distal slot 284. At the distal end of theconnector is a prong 286 configured to pass through the prosthetic bandand effectively provide a permanent lock. The friction provided by thecombined slot edges through which the band is passed as well as theprong provide a temporary fixation as described earlier so that thesurgeon may assess for proper reduction. Because it may not be desirableto have a prong protruding upward into overlying soft tissue, the prongmay be made of a material and configured so as to be deformable. FIG. 24show the prong in a deformed state. The deformed prong 288 also ensuresthat the prosthetic band cannot be easily removed, thus forming a morepermanent lock. When used with connectors of this type (prongs), theprosthetic band may be configured to have enhanced strength across thewidth of the band which resists the forces of the prong in thelengthwise direction. This may prevent the prong from effectivelytearing through the band material. These strengthened sections acrossthe width of the band may be created at discreet intervals so as toallow incremental tensioning of the band. Processes which may providethe bars or rungs of reinforcement include heat-staking and sewing ofthick weft threads across the width.

FIG. 25 is another embodiment of a buckle-type connector. Like previousembodiments, one end of the prosthetic band 290 may be fixedly attachedto the connector. The other end of the connector is configured with areceiving slot 292 and a locking slot 294. Over the locking slot 294 isan archway 296 of material which may be formed by a lancing operation.When the free end 298 of a prosthetic band is fed up through the lockingslot then slipped under the arch, temporary fixation is achieved. Bydeforming the arch downward and thus forcing the band down into thelocking slot, a more permanent fixation is achieved.

FIG. 26 is an embodiment of another connector for the prosthetic band.This is a simple crush tube configuration with opposing slots. When theends of the prosthetic band are passed through the lumen of the tubeeither together in the same direction or in opposite directions, thetube may be crushed or flattened, effectively pinching and trapping theprosthetic band. To this end, the connector utilizes a crimpingoperation to close the connector. To provide this function, theconnector is made of a deformable, self-holding material, such as metal.The opposing slot configuration allows for the band material to beforced into the open space 295 of each slot, and thereby being furtherretained by irregular edges 293 of the slots.

The connector of FIG. 27 has a main housing 300 with an open passagewayor channel there through for the passage of the prosthetic band 302.While one end of the passageway is open, the other may be partiallyclosed by a deformable gate 304. The gate may be configured with teeth306 along the front surface to better engage the band. The gate may beconfigured so as to allow passage of the band in the direction of thegate, yet applying some compression to the band so as to make itdifficult to pull the band in the opposite direction. At the other endof the connector, a pivoting, generally triangular-shaped arm 308 mayrotate inward to apply compression to the band. The pivoting arm 308 isrotatably attached to the main housing 300, and is configured with teeth310 resembling a gear or ratchet. The pivoting arm is also configuredwith a locking tab 312 which engages a window 314 on the main housing.Once fully engaged, the tab 312 snaps irreversibly into the window 314,and the prosthetic band 302 is permanently locked into place.

In the cut away view of FIG. 28, the band 302 can be seen lying in thechannel with the pivoting arm 308 in a more or less neutral state. Inthis state, the band 302 is free to move in the direction shown by thearrow. FIG. 29 is another cut away view of the same embodiment as FIG.28 in which the band has been moved in the direction of the arrow, whichhas engaged the pivoting arm 308 into a locking position. When the band302 is moved in this direction, the teeth 316 at the leading edge of thepivoting arm 308 begin to engage the band and the further the band ispulled, the more the arm pivots to engage the band, in essence clampingtighter and tighter. This serves well as the temporary fixationdiscussed previously, in that the band is prevented from moving in theopposite direction by the tension normally placed on the band duringinstallation. Thus, the band 302 does not loosen, and remains releasableby removing the tension in the band until the pivoting arm 308 ismanually pushed in far enough to engage the lock mechanism (i.e., thetab engaging the window), at which point the band is permanently fixedin the fully engaged or clamped position as shown.

FIGS. 30-32 show an embodiment of a connector which has a doubleclamping mechanism. In FIG. 30, a housing 320 is shown with a channel322 (best shown in FIG. 31) in center for passage of the prosthetic band324. Two clamping tabs 326 are disposed in the sides of the housing withthe flat part of the tab protruding out of slots 328 in the sides of thehousing. The inner aspect of each tab is disposed with teeth 330 whichmay be disposed to be directional in nature. Each tab has two pins 332that protrude upward from the tabs to engage angled slots 334 in the topand bottom of the housing. When the band is pulled in the direction ofthe angled slots, the teeth on the tabs engage the band and the anglednature of the slots pulls the tabs toward the center, thus clampingtighter on the band. Like the embodiment of FIGS. 27-29, this isessentially a self-tightening mechanism in one direction of band pull.FIG. 31 is a cutaway view showing the tabs 326 in a neutral position.FIG. 32 shows the tabs 326 clamping on the band when the band is pulledin the direction indicated by the arrow. In embodiments the clampingtabs may be disposed with a tab lock as in the embodiment of FIGS.27-29. The tabs may further be compelled into a locking position bysqueezing them inward with a surgical clamp, forceps or the like.

FIGS. 33-35 show an embodiment of a connector with a cam lever lockingmechanism. One end of a prosthetic band 340 may be fixedly attached tothe connector as shown in FIG. 33. The other end of the connector has areceiving slot 342. Mounted to the housing just inside the receivingslot is a lever arm 344 with the pivot point 346 located in the middleof the housing just inside said slot. Disposed on the pivot at an angleto the lever arm is a locking cam 348 which may have teeth to betterengage the band. In FIG. 34 a locking slot 350 is shown disposed in thebottom surface of the housing just below pivot. When the pivoting leverarm is in the upright position, a prosthetic band may pass through thereceiving slot and under the pivot arm and out though a slot 352 on theopposite end of the connector. Once the band is appropriatelypositioned, the lever arm 344 is pivoted down in the direction indicatedby the arrow which brings the locking cam 348 around, forcing it to pushthe band down into the locking slot. FIG. 35 shows the pivot armcompletely closed with the locking cam fully engaged to trap the band inplace. A final lock tab 354 may be folded down to permanently affix thelever arm in the locked position. Until this final lock tab 354 isdeployed, the lever arm may be raised, allowing the band to slide againso that the tension may be adjusted. Again, this embodiment providesboth a temporary lock and a permanent lock.

FIGS. 36-37 show an embodiment of a connector for securing a prostheticband utilizing suture stitches through slots. A prosthetic band 358 ortwo ends of a band are passed through the central channel of theconnector. A deflectable tab 360 with teeth 362 may be used to providetemporary fixation. The connector is disposed with one or more slots 364through both the upper and lower surfaces of the housing. As shown insection view of FIG. 37, once the band is tensioned, typical orthopedicsutures 366 may be passed in and out through the slots and the suturesmay cross from one slot to another. This suture stitching provides apermanent fixation.

FIG. 38 is yet another embodiment of a connector used to fix aprosthetic band. At one end 370 of the connector the prosthetic band ispermanently fixed. The other end of the connector has an opening for apassageway that extends the length of the connector. The free end 372 ofthe prosthetic band is fed through the passageway and under a series ofalternating deflectable flaps 374. In embodiments, one or more of theflaps may be deflected enough so as to contact the band to providetemporary fixation. Once the band is properly positioned and tensioned,the flaps may be deflected downward into the channel to pinch or trapthe band. This provides permanent fixation.

FIGS. 39-40 show another embodiment of a prosthetic band connector witha simple pivot arm retention mechanism. FIG. 39 shows a perspective viewof the embodiment. Like previous embodiments, the connector housing isconfigured with a passage way 380 for passing of the band. A pivot leverarm 382 is show configured with multiple protrusions 384 for engagementof the band, though other embodiments may be configured with a singleprotrusion.

FIG. 40 shows a section view of the embodiment of FIG. 39. One end 386of the band may be fixedly attached as in other embodiments. The freeend 388 of the band is passed through the passageway opposite the fixedend when the pivot arm 382 is positioned up. When proper tensioning isachieved, the pivot arm 382 is rotated down to essentially clamp theprosthetic band, thus providing retention. The under surface of thepivot arm may be configured with protrusions which may be configuredwith pointed tips so as to better retain the band. Slots 392 may beconfigured on the bottom surface of the housing so as to receive theprotrusions and band. Final or permanent locking may be achieved bydeflecting the locking tab 390 downward, thus preventing the arm frommoving.

As mentioned previously, when performing these AC jointrepair/stabilizations and similar surgical procedures, doing so in aminimally invasive fashion is highly beneficial. To this point we havedisclosed various implants for methods for stabilizing the bones andaugmenting the ligaments. However, to place these implants in aminimally invasive fashion, specialized instruments are utilized. Theseinstruments gain access to the deep-lying bones which are surrounded bysoft tissue.

Disclosed presently, is passing instrumentation allowing a minimallyinvasive or arthroscopic approach to placing a prosthesis or a passingsuture around both superficial and deeper-lying bones. The passinginstrumentation disclosed is particularly useful for facilitating thepassage of a prosthetic band of the type disclosed up to this point.

The prosthetic bands disclosed herein for stabilization and/oraugmentation of the damaged ligament structures are placed around bonystructures to avoid hole-drilling. In embodiments, instruments describedherein provide access to the majority or all of a circumference of oneor more bones, allowing installation of a band around the one or morebones. Gaining access to the underside of the bone, particularlydeep-lying bones, is technically demanding. Further, gaining access totwo sides of the bone in addition to the underside of the bone in orderto place a prosthetic band is difficult to achieve.

Proposed now is an instrument designed with an elongated cannula forinsertion into tight spaces and adjacent to one or more bones. Theinstrument utilizes a shape memory alloy element to circumvent a bone.Said shape memory element is designed to curve tightly around the bonewhile carrying a passing element which will be used to place theprosthetic band. In addition to curving tightly around the bone, theshape memory element maintains sufficient rigidity or stiffness towithstand the forces needed to extend through the soft tissue adjacentthe bone. Such a passing instrument and associated elements are shown inFIGS. 41-46.

FIG. 41 is a schematic illustration showing the bones of the shoulderjoint with a passing instrument 405 in accordance with embodimentsinserted. The elongated cannula 410 of the passing instrument 405 isplaced alongside the clavicle bone 412 and abutted to the coracoid bone414. The distal end of the cannula 410 may be straight or configuredwith a bone-location feature. The bone location feature of thisembodiment is a curve 416 or bend at the appropriate position of thecannula so as to position the opening of the cannula at the optimalpoint on the bone for deploying the shape memory element. Otherembodiments of bone-locating features are described in detail later.Shown protruding from the distal opening of the cannula is a shapememory element 418. This shape memory element 418 carries with it apassing element 420 which is releasably attached to the to the tip ofthe shape memory element. The shape memory element is compelled to exitthe cannula tip by a translator located within the proximal housing 422and operated by the user. The passing element 420 is releasably affixedat its proximal end to a return spool 424 that is internally affixed tothe translator, such that when the shape memory element deploys out thedistal tip of the cannula, the return spool 424 moves forward as well.This relationship allows the passing element to move forward with theshape memory element 418 as the shape memory element encircles the bone,while maintaining tension of the passing element 420 against the back ofthe shape memory element. Thus, tension that was initially created whileattaching the passing element is maintained as the shape memory elementis deployed.

FIG. 42 is a continuation of this passing sequence. Here the shapememory element 418 is shown further advanced around the coracoid bonewith the passing element in tow. To achieve this, the passing element420 must typically remain in some tension along the back of the shapememory element 418 from the distal tip of the attachment of the passingelement to the shape memory element to the proximal attachment of thepassing element to the return spool. As described above, this functionis provided by the tension that remains in the passing element due tothe spool 424 moving with the shape memory element 418 as the shapememory element is deployed. In addition, the passing element 420 isfurther tensioned as the shape memory element 418 bends.

After the passing element 420 is extended around a bone, it is graspedand released from the shape memory element 418. A surgical grasper 426or other appropriate surgical instrument is shown in position in FIG. 42to retrieve the passing element 420. By deploying the shape memoryelement 418 substantially around the bone, the passing element 420 isthen in a position to be retrieved from a port or superiorly locatedsmall incision. Alternatively the passing element 420 may be retrievedfrom a port more inferiorly or laterally located. This may require lessdeployment of the shape memory element 418 around the bone.

In FIG. 43, the proximal end 428 of the passing element 420 is showndetached from the return spool 424 to release the tension in the passingelement, so as to allow for easier retrieval of the distal end 430 ofthe passing element. The surgical graspers or like instrument is shownin the process of pulling the passing element out of the body. The shapememory element 418 is shown in a partially retracted state. After thepassing element 420 has been retrieved, the shape memory element 418 maybe fully retracted back in to the cannula 410.

In FIG. 44, the passing instrument 405 has been fully retracted from thebody and the passing element 420 is positioned such that the centralportion of the passing element is under the coracoid bone 414 and thetwo free ends exit the port or incision in close proximity. With thepassing element 420 in place, other elements such as an implant or oneor more additional passing elements may be attached to the passingelement and pulled into the subcoracoid position. A prosthetic band 432,such as many of the bands described above, is shown inserted into theproximal loop 434 of the passing element 420, and is ready to be pulledinto place.

In FIG. 45, the distal end of the passing element has been pulled todrag the prosthetic band under the coracoid and superiorly above theclavicle. This embodiment shows the prosthetic band 432 fully doubledover. One of the ends may be pulled around under the coracoid if desiredto result in a single band passage under the coracoid.

In FIGS. 41-45 demonstrate passage under the coracoid bone. Within theAC joint, the passing instrument and same passing method may be used tocircumnavigate the clavicle as well. FIG. 46 shows the passinginstrument 405 of FIGS. 41-45 being used to circumnavigate the claviclebone.

In FIG. 47 is a perspective view of an embodiment of the passinginstrument of the present invention. The generally pistol-shapedinstrument 500 has a proximal handle 502 with a distal cannula 504(e.g., the cannula 410) rigidly affixed thereto. As discussedpreviously, the distal end of the cannula 504 has a curve 505incorporated which acts as a bone-location feature when the cannula isplaced alongside a bone to be circumnavigated. The cannula 504 is ofsufficient length to easily reach the deeper lying bones of a joint,typically 3″ to 8″ in length beyond a handle housing 506. The proximalportion of the handle housing 506 is generally shaped to be gripped inthe palm with a large actuation trigger 508 extending from a verticalgrip area 510. In an embodiment, the actuation trigger 508 may beconfigured with gripping features 509 which may be in the form of one ormore bumps, grooves, undulations, slots, knurls, or other surfacedisruptions in an effort to enhance the users grip on the actuationtrigger. A passing element 512 (e.g., the passing element 420) issituated on the device with its distal end releasably affixed to adistal tip of a shape memory element 514 (e.g., the shape memory element418). The passing element 512 extends proximally to attach to a returnspool 513 (e.g., the spool 424) disposed on the side of the housing 506.In an embodiment, the passing element 512 is a suture and is woundaround the return spool in tension and pulled into a thin slot 516 onthe front face of the spool, with any excess length 518 of the passingelement 512 left to dangle. The thin slot 516 pinches the suture andprovides secure retention. The return spool 513 is internally affixed tothe return trigger 520 and is directed for sliding movement distally andproximally along a slot 522 in the housing. In embodiments, a guidingfeature 515, such as an elongate groove, may be disposed at the distalend of the handle housing 506 in order to maintain the direction andlocation of the passing element 512 along the length of the distalcannula 504.

Prior to using the instrument to pass an element, the passing element512 is affixed to the instrument as shown and the shape memory element514 retracted fully into the cannula 504 by retracting the returntrigger 520. When the passing instrument is abutted to the bone, theshape memory element is deployed out the distal tip of the cannula bypulling an actuation trigger 508.

In FIG. 48 is a perspective cut away view showing the internal mechanismof the passing instrument of the embodiment of FIG. 47. In general, thepassing instrument 502 is designed to work like a typical caulk gun,where the actuation trigger 508 is engaged to index the shape memoryelement 514 out of the cannula 504, and the return trigger 520 isengaged to incrementally retract the shape memory element 514. The shapememory element 514 includes a curve-biased distal end, which is flexibleso that it can retract into a straighter position within the cannula504, but resilient in that the distal end curves into its biased shapewhen the distal end is incrementally indexed outward from the end of thecannula 504. With each pull of the trigger 508, incrementally more ofthe shape memory element 514 is deployed out the distal tip of thecannula 504 and the distal end of the shape memory element returns toits generally circular, preformed, biased shape and specified diameter.Incremental deployment permits proper function and safe deployment ofthe shape memory element 514 around a bone. By pushing the shape memoryelement 514 forward in small increments, the surgeon can monitor theprogress of the distal end and assure that the shape memory element istracking properly around the bone. If it is determined that the shapememory element 514 is not tracking properly, the return trigger 520 maybe used to retract the shape memory element for another attempt.Additionally, the incremental deployment permits the shape memoryelement 514 to push through soft tissue surrounding bone a little bit ata time, and to determine whether bone is engaged during movement, so asto properly realign the tip of cannula 504. By contrast, if the shapememory element were pushed out quickly all at once, the tip is prone tocatching in soft tissue and becoming stuck, while the rest of the shapememory element deploys in the improper location below the bone. The tipconfiguration, as discussed later, also enhances the ability of theshape memory element to pass through soft tissue and not drive directlyinto the bone and be stopped from further extension.

Returning to the trigger actuation, the actuation trigger 508 pivotsaround a pivot pin 524. An actuation rod 530 is affixed to the shapememory element 514 (best shown in FIG. 49) and is axially translatablewithin the cannula 504. A slide plate 528 is mounted on a proximal endof the actuation rod 530, and includes an opening therethrough. Theopening is sized to receive the actuation rod 530 and hold the rod whenthe slide plate 528 is tilted or canted relative to the actuation rod,yet allow sliding of the rod through the opening when the rod isgenerally perpendicular to the plate. An actuation head 526 of thetrigger 508 engages the plate 528 when the trigger rotates about thepivot pin 524. A plate spring 536 is mounted on the actuation rod distalto the slide plate 528 and proximal to the trigger 520.

Three O-rings 532 are seated around the actuation rod 530 in the rearpart of the housing 534. These O-rings are trapped within ribs in thehousing and thus not movable. Their purpose is to provide a retentivefriction force against sliding movement of the actuation rod 530. Thismay be required because the radial force generated by the bias of theshape memory element compels the shape memory element forward and outthe tip of the cannula. The O-rings provide enough friction tocounteract the radial force of the shape memory element and prevent itfrom exiting the cannula tip of its own force.

An anchoring block 540 is rigidly fixed to the distal cannula 504. Theanchoring block 540 is in turn immovably affixed in the housing 506 andhas the purpose of providing a substantial connection means to thehousing.

FIG. 49 is an exploded view of the embodiment of FIG. 48, minus thepassing element 512. In this view, a left handle housing 501 and a righthandle housing 503 are shown, which when assembled together comprise theproximal handle housing 506. The handle housings 501 and 503 are heldtogether with locator pins 548 which may provide a friction fit using ataper or deformable ribs. One or more screws 550 may be used incombination with or instead of the locator pins 548. A connection 552 isshown between the shape memory element 504 and the actuation rod 530. Inan embodiment, the end of the shape memory element fits into a slot inthe end of the actuation rod and is held there with a weld or adhesive.Pockets 554 in the left handle housing 501 accommodate the O-rings 532.

To propel the shape memory element 514 out of the distal end of thecannula 504, the trigger 508 is squeezed. The actuation head 526 pushesagainst the slide plate 528. When the trigger 508 is pulled and theactuation head 526 pushes against the bottom section of the plate 528,the plate is canted forward and by virtue of the hole also canting, theplate grabs the actuation rod 530 and pushes it incrementally forward.Since the actuation rod 530 is affixed to the shape memory element 514and is axially translatable within the cannula 514, the shape memoryelement is pushed incrementally out the tip of the cannula. A typicalincrement distance may be in the range of 0.05″ to 0.5″, with optimalperformance being achieved at around 0.1″. When the trigger is released,the plate spring 536 pushes the slide plate 528 back to its startingpoint. This process continues to incrementally index the shape memoryelement 514 outward.

In embodiments, the passing instrument disclosed herein providesfeatures that aid in appropriate positioning of a distal end of thecannula 504 (referred to herein as a “distal cannula”) against the bone.In an embodiment, this is accomplished with previously disclosedcurvature in the distal portion of the cannula 504. This configurationallows the user to abut the curvature against the side of a bone, whichgenerally has a curved outer surface, thus providing the requiredposition and stability of the cannula in relation to the bone. Disclosednow in FIGS. 50-52 are further embodiments of bone-locating featurerelated to the distal cannula.

FIG. 50 shows a generally straight distal cannula 600 with abone-locating protrusion 602 configured on the outside of the cannula.This embodiment of the protrusion 602 has a generally rounded top 604and sloped sides 606. In embodiments, the protrusion may have straightsides and a flat or pointed top. The protrusion 602 is located at adistance from the opening 608 of the cannula, typically correspondingwith the size of the bone(s) being circumnavigated.

FIG. 51 shows a similar protrusion 610 to the one disclosed in FIG. 50configured in combination with a curved cannula as disclosed in previousembodiments. The combination of both the curve 612 and the protrusion610 may provide a better, more tactile, and stronger holding bonelocation function.

FIG. 52 shows another embodiment of a bone-locating feature. In thisembodiment a slot 620 is configured in the distal canula 622. Aresilient prong 624 eminates from the slot and is configured so as toabut a second surface of the bone to provide a stop. In embodiments theprong may be retractable into the cannula to provide a lower profilewhen inserting the passing instrument into tissue. In other embodimentsthe prong may be configured so as to temporarily flex or bend out of theway of tissue and other objects. The prong may be configured from metalsuch as stainless steel or nitinol or thermoplastic materials. Inembodiments, the prong may also be affixed to the outer surface of thecannula or be formed from the cannula itself.

Also disclosed herein are features on the distal cannula to interfacewith the passing element. As described previously, the passing elementmay be detachably connected to the distal tip of the shape mory element(shown in FIG. 47). It is important when operating the passinginstrument that the passing element remain in close approximation to thedistal cannula and the proximal housing. This ensures proper alignmentand movement of the passing element as it moves back and forth in theprocess of encircling a bone.

FIG. 53 shows an embodiment of a passing element control feature. Inthis embodiment, the feature is a notch or slot 650 in the under side ofthe cannula 652. The slot is generally “V” shaped in the drawing, but itcould be “U” shaped in alternate embodiments. When the shape memoryelement is deployed to any degree with the passing element releasablyattached at the tip, the the passing element travels between the twosides 654 of the slot, keeping the element positioned in the center ofthe cannula and the center of the shape memory element. Thus, the slotprovides proper operation of the passing instrument and keeps thepassing element properly positioned throughout the passing operation. Itshould be noted that any of the disclosed passing element controlfeatures may be applicable to various embodiments of the cannula aswell.

FIG. 54 shows another embodiment of a passing element control feature.In this embodiment two ribs 658 protrude orthogonally from the distalcannula 660. The inner sides of said ribs serve to control the locationof the passing element and guide it down the cannula in the same manneras the slot of the previous embodiment.

FIG. 55 shows another embodiment of of a passing element controlfeature. In this embodiment, a hole 664 is configured in the bottomsurface of the distal cannula 666. The passing element is threaded intothe hole which is sized such that the passing element readily fitsthrough it, yet it maintains adequate control of the passing element.

As stated above, in accordance with embodiments, the shape memoryelement includes a curve-biased distal end, which is flexible so that itcan retract into a straighter position within the cannula, but isresilient in that the distal end naturally curves into its biased shapewhen not under the influence of the cannula or other outside forces.Thus, when the shape memory element is incrementally deployed from thetip of the cannula as described previously herein, it assumes agenerally circular or arched shape, facilitating its passage around abone.

In an embodiment, the shape memory element is made of nitinol, althoughother materials can be used that have a resilient memory for returningto their original positions, are flexible so that they can straightenwhen needed, and are sufficiently stiff to penetrate soft tissue withoutbending excessively.

The need to straighten and then curl is a function of the tight workingconditions of the procedure. In embodiments, as described above, thecannula is inserted orthoscopically, with a need for the cannula to begenerally straight for directing the distal cannula to a bone. Incontrast, the shape memory element needs to curve dramatically tocircumnavigate the bone.

Applicants have found that to meet the above properties, a materialshould have sufficient elasticity to withstand repeated bending from itsnatural curved shape, to a flattened shape within the cannula, withoutfailure. Otherwise, if flattened by the cannula, the shape memoryelement can have failures at molecular bonds, resulting in local orcatastrophic breakages, and preventing the shape memory element fromreturning to its natural curved shape.

To extend into a hoop with a tight enough circle to circumnavigate abone and then be able to straighten into a cannula, applicants havefound that a material should have an ability to withstand elongation ofat least 3%, and more preferably 5%, and most preferably around 8% ormore.

In an embodiment, the shape memory element is made of nitinol, whichtypically has a maximum elastic strain of approximately 8%. As this 8%elastic strain limit is approached and exceeded, the shape memoryelement may not return fully to its intended preformed shape and thusnot function properly for its intended purpose of encircling the bone.To achieve the curved shape in nitinol, the flat, elongate, generallystraight piece of nitinol is constrained in the desired circular shapeand brought to a temperature of approximately 500 degrees C. for aperiod of time, usually in the range of 10 to 20 minutes.

Applicants have also found that, for the shape memory element topenetrate soft tissue around the bone, the shape memory element musthave sufficient radial stiffness. That is, the shape memory element mustresist bending from its looped shape while being deployed around thebone. There is a significant amount of soft tissue around any given boneand it must be overcome by the stiffness of the shape memory element. Inembodiments, the loop of the shape memory element is approximately equalto, or smaller than, the diameter of the bone to be circumvented. Inthis manner, the loop hugs the bone as it is extended to circumnavigatethe bone. In an embodiment, a shape memory element loop diameter of0.65″ is formed with a ribbon of 0.03″ thick and 0.112″ wide forcircling a coracoid bone. A thickness range of 0.015″ to 0.06″ may beappropriate for the proposed application combined with a width range of0.05″ to 0.25″. The loop diameter may be appropriate in the range of0.3″ to 1″, and functions more optimally when it is slightly smallerthan the bone. Ideally the shape memory element should be as thick aspossible without exceeding the strain limit of the material, however itmust be noted that the thicker the material, the greater the resistanceof the surrounding soft tissue to penetration. This may be at leastpartially overcome with an appropriate tip configuration, as explainedlater. In short, an element of optimal radial stiffness that does notexceed the post processing strain limit of the material combined withthe appropriate tip configuration allows the passing of a shape memoryelement around a bone.

As indicated above, in embodiments, the shape memory element isconstructed of nitinol, and as has been established has a preferred loopdiameter, width and thickness in order to achieve appropriate radialstiffness. Another property that may impact the radial stiffness is theinherent Austenite Finish (Af) Temperature of the nitinol. This is thetemperature at which the transformation from austenite to martensitefinishes upon heating the material and is commonly used to specify anitinol alloy. For the application described herein, an Af temperaturein the range of −20° to 20° C. can be utilized. In order to achievetemperature below 10° C. an additional element such as Chromium may needto be added to the alloy. This alloy is known as Chromium Doped Nitinoland as a result of the lowered Af temperature, can increase the radialstiffness of the shape memory element. With this inherently increasedstiffness, the thickness of the shape memory element may be lowered,while still maintaining a high radial stiffness for a given loopdiameter. This allows for a thinner shape memory element of equalstrength, thus providing functional advantages as the shape memoryelement pushes its way through soft tissue while circumventing a bone.

Shown in FIG. 56 is an embodiment of a shape memory element. The primaryloop 670 is generally circular and the flat section 671 may be attachedto an actuation rod. The distal tip 672 is configured with two opposingslots 673 for the attachment of a passing element. The tip is rounded soas to not damage any unintended soft tissue structures as it encirclesthe bone.

Because the shape memory element is ideally of a diameter slightlysmaller than the bone it encircles, there is a tendency, when the shapememory element has a constant radius at the loop, for to become stuck onthe outer surface of the bone as the tip is advanced around the circularpath. In other words, the tip will have a propensity to dig itself intothe bone when trying to navigate its circumference. For this reason, thetip is ideally shaped to straighten or bend slightly outward as with ashepherd's hook. The profile view shown in FIG. 57 is of the sameembodiment as that of FIG. 56. From this view it can be seen that thedistal tip 672 of the shape memory element does not continue the samecircular path as the rest of the loop. Instead, there is a slight bend674 or straightening outward of the element at the tip. This straightsection or outward bend prevents the tip from becoming stuck in thebone.

As mentioned previously, penetration through soft tissue surrounding thebone is necessary. Therefore the sides 678 of the distal tip are beveledin an embodiment as shown in FIG. 58. In embodiments, the beveled edgesterminate in a small radius 680, while in other embodiments, the bevelededges continue to a sharp edge. Other embodiments may also include apointed tip similar to a needle for better penetration of soft tissue.

As described earlier, the passing element is releasably attached to thedistal tip of the shape memory element. FIGS. 59-61 show embodiments ofpassing element attachment configurations. FIG. 59 shows an embodimentof a distal tip/passing element configuration. The distal tip, as shownin previous embodiments, has two opposing angled slots 690 into whichthe passing element 692 rests as it is looped around the tip. The slotsserve to hold the passing element in place after it is tensioned duringloading. In embodiments the slots are straight across from each other,rather than angled. This configuration has the advantage of keeping bothlegs 694 of the passing element disposed on the back 696 of the shapememory element. This works in concert with the previously describedpassing element control feature in FIGS. 53-55 to keep the passingelement aligned properly on the instrument as well as the shape memoryelement.

FIG. 60 is an embodiment of another distal tip/passing elementconfiguration. In this simple configuration, a single notch 698 isdisposed on the tip, through which the passing element 699 passes.

FIG. 61 is another embodiment of a distal tip/passing elementconfiguration. In this embodiment a single post 682 is disposed at thetip of the shape memory element around which the passing element iswrapped. In embodiments, various configuration of wraps may be utilized.In the embodiment shown, after completing several wraps 684 around thepost from the bottom upwards, the end is turned and fed back down underthe existing loops similar to a fisherman's knot on a hook. Theembodiment shown also includes the use of opposing notches 686 to guidethe passing element onto the back of the shape memory element.

The passing element in embodiments may be a flexible member such as asuture or wire. In the case of a wire embodiment, one braid of smalldiameter filaments may be preferable in that it may better retain itsflexibility. The wire may be stainless steel or nitinol or othersuitable biocompatible metal.

FIGS. 62-65 show embodiments of passing elements that are formed fromvarious configurations of suture. In an embodiment of a passing elementshown in FIG. 62, a single suture stand 700 is configured with a loop702 on each end. The loops may be the same strand that is looped overand knotted or manufactured as a bifurcated braid. The primary functionof the two loops is for passage (pulling) of a prosthetic band or tendongraft in either direction, after the suture strand 700 has been passed(see, for example, FIG. 44). Further, a passing suture may be used topass multiple other passing sutures. All of the embodiments shown areappropriate to work with disclosed embodiments of shape memory elementsand passing instruments.

The embodiment shown in FIG. 63 is similar to the double embodiment ofFIG. 62 with the addition of tabs 704 on each end near the loops toprovide something to grab with surgical instruments when using thepassing instrument.

The embodiment of FIG. 64 is a single continuous loop 706 of suture. Theends of the loop may be tied together in a knot or in embodiments may bebraided or heat-staked together.

The embodiment of FIG. 65 is a single suture strand with knots 708 ineach end.

FIGS. 66 and 67 show an embodiment of a passing cap 708. The passing capfacilitates connection of the passing element to the shape memoryelement. The passing cap 708 adds the advantage of providing a moresubstantial element that the user may grab when passing. Further, thecap 708 may be useful for passing instrument embodiments wherein it isdesired to deliver the passing element back to the cannula. FIG. 66shows a braided cap 708 preferably made of flexible material such assuture or small gage wire. A passing element 710 is shown passingcompletely through the cap from one side to the other. This is easilyaccomplished with a woven structure for the cap 708, which allowspassage of needles, etc., through the fiber of the weave. FIG. 67 is aview of the passing cap 708 with passing element 710 attached andmounted onto a shape memory element 712. In alternate embodiments, apassing cap may be constructed of solid flexible material such asrubber, silicone or molded thermoplastic.

In surgery, it may be beneficial for the shape memory element to deliverthe passing element construct all the way around the bone and reattachit to the cannula or a passing element-receiving feature thereon. Oncethe passing element has circumvented the bone and is reattached to thecannula, the cannula may be retrieved with both ends of the passingelement intact, thus saving the surgeon time and effort. Thus, thepassing element receiving feature can provide a passing element througha single opening in a patient. Embodiments below discuss asuture-receiving feature, where the passing element is a suture, butalternate embodiments can be utilized with any type of passing element.

FIG. 68 is an embodiment of a suture-receiving feature on the distal endof the cannula of the passing instrument. A shape memory element 720 isshown encircling a bone 722. The distal tip of the shape memory elementis configured with a passing cap 724 of the type of embodiments 66-67with a passing element 725 in tow. When the shape memory element hasincrementally encircled the bone and reaches the cannula, it passesthrough two opposing cantilever elements 726. The tips of the elements726 are spaced such that they have to deflect to allow passage of thepassing cap. Upon retraction of the shape memory element 720 back intothe cannula 728 as shown in FIG. 69, the passing cap 724 and associatedpassing element 725 are trapped on the outer surface of the cannula. Nowboth ends of the passing element may be retrieved simultaneously fromthe same direction by retracting the cannula.

FIG. 70 is another embodiment of a suture-receiving feature on thedistal end of the cannula of a passing instrument. This embodiment has awire or suture snare 730 retractably mounted on the cannula 732 andpositioned so as to receive the shape memory element 734 as itincrementally encircles the bone 736. The shape memory element carriesat its tip a passing element similar to that of embodiment of FIG. 65with knots in the end of a suture 738. As the knots 738 pass into thesnare 730, the snare may be retracted to capture and pull the passingelement from the shape memory element as show in FIG. 71.

FIG. 72 shows an embodiment of the prosthetic band and a connector usedin an ankle syndesmosis repair. The syndesmosis is where the tibia andfibula bones meet near the ankle. When the ligaments supporting thisjoint are damaged, the bones tend to separate and require support forhealing. In FIG. 72, a prosthetic band of similar configuration asdisclosed previously herein is stretched through a transverse holethough the two bones. Buckle-type connectors of similar configuration asdisclosed previously herein are used to tension and anchor the bones ateach end of the hole. Alternatively, a passing instrument as disclosedherein may be used to circumnavigate the bones and place a passingelement around the bones which is then used to pull a prosthetic bandinto place around the bones where it may be tensioned and anchored witha connector of any of the embodiments disclosed herein.

Turning now back to prosthetic band systems for stabilizing the ACjoint, FIG. 73 shows a shoulder with an AC joint separation 800, whereinthe clavicle bone 802 is displaced superiorly with respect to thecoracoid bone 804. A prosthetic band 806 with an integrated connector808 as described in previous embodiments is shown looped under thecoracoid and over the clavicle. The tip of the prosthetic band is showthreaded though the receiving slot in the connector. In order to reducethe superiorly displaced clavicle, the prosthetic band must be tightenedor cinched down over the clavicle. This can often be difficult,particularly in a minimally invasive surgical setting, due to the sizeof the connector and limited working space. In this instance, a countertraction tool 810 may be used to engage and stabilize the connectorduring the tightening or cinching process. The counter traction tool 810may be disposed with a feature 811 that engages the connector to providebetter stabilization of the connector. Such a feature may be in the formof a recess, groove, dimple, post, or other form that may providemechanical engagement with the connector.

FIG. 74 shows the AC joint of FIG. 72 with the clavicle bone 802 in areduced state by virtue of the tightened/cinched prosthetic band. Thecounter traction tool 810 is shown actively engaged with the connector,holding it stable against the clavicle bone. This allows the prostheticband tip 812 to be pulled with significant force while maintaining theposition of the connector against the clavicle. A locating feature 813in the form of a hash mark is shown on the end of the counter tractiontool which may correlate to a similar mark on the connector in order toprovide the user with visible landmarks for orienting the countertraction tool with the connector. Said mark is ideally a laser mark butmay also be pad printed or otherwise adorned on the tool and connector.

Another adjunct tool that may facilitate the use of prostheticband/connector system is the punch tool. In an embodiment, the punchtool is an automatic center punch as described earlier in thisapplication, but may be simple punch requiring a mallet to deflect thecleat on the connector. Other tools may be used to deflect the cleat andlock the connector including but not limited to surgical graspers,pliers or needle drivers. FIG. 75 shows a prosthetic band 826 situatedwithin the connector 828 and placed under the cleat 830 in the temporarylocking mode. A punch tool 820 is shown with the punch tip 822 alignedto engage one of the dimples 824 on top of the cleat. FIG. 76 depicts acontinuation of FIG. 75 wherein the punch tip 122 is fully engaged withthe connector cleat 830 and has deflected it downward so as toeffectively lock the prosthetic band within the connector.

In the process of surgically repairing an AC joint separation, it may bebeneficial to create stabilization across the actual acromioclavicularligaments. This may be accomplished by spanning said joint by securing aprosthesis, suture, plate or the like to the clavicle and acromiumbones, such as is shown in FIG. 77. A prosthetic band 841 is affixedaround the clavicle and coracoid bones using a connector 842 asdisclosed previously in this application. The connector 842 is disposedwith an additional attachment point 844 which is configured to receiveand affix a second prosthetic band 848 using methods previouslydescribed. In this embodiment, the prosthetic band 848 is configuredwith a prefabricated loop 843 allowing it to be attached to the acromium846 in a luggage-tag type arrangement. Such an arrangement, with theprosthetic band spanning the acromioclavicular joint 840, may provideadditional stabilization during healing.

FIG. 78 shows an additional embodiment of an AC joint-spanning repair.In this embodiment, the connector 850 is disposed with an additionalattachment feature 851 which is configured to receive suture strands orcables. In this embodiment the feature 851 is in the form of holes orslots through the connector. The sutures or cables loop trough theattachment feature 851 holes/slots and span the AC joint where they areaffixed to the acromium via bone tunnels 854. The bone tunnels 854 maybe added during a procedure, for example, as described in earlierembodiments, by drilling holes in the bone. The suture or cable may passthrough the bone tunnels 854 and terminate on the other side of theacromium using knots, pledgets, buttons or the like. Alternatively, thesutures or cables may pass through the bone tunnels 854 and span thejoint again on the underside, ultimately returning and passing throughbone tunnels (not shown) in the clavicle. In other embodiments thesutures may be anchored to the acromium using typical bone sutureanchors rather than boring bone tunnels all the way through the bone.

As mentioned previously, many surgeons use tendon allograft as part oftheir AC joint repairs. In some cases, they may use only tendonallograft. The passing tool described earlier in this application may beused to help pass the tendon allografts around the coracoid and claviclebones, however, the tendon would typically then be tied in knots overthe clavicle and bolstered with suture stitches to prevent knotloosening. This process is tedious and results in a very large,undesirable tendon knot stack due to thick nature of the tendon. FIGS.79-82 describe techniques and embodiments of devices to facilitateaffixing of the tendon graft around the bones in an AC joint repairprocedure.

FIG. 79 shows a tendon allograft 860 that may be looped around thecoracoid and clavicle bones in a similar fashion to the prosthetic bandsdescribed herein. Because the typical tendon graft is quite flaccid, itmay be challenging to thread into a connector for fixation. A tip 862may be affixed to the tendon graft in order to allow easier interfacewith a connector. The tip 862 is generally flat in nature and may becomposed of metal or plastic. In this embodiment, said tip is anelongated flat metallic tab that is crimped over the end of the tendongraft. The tip may be disposed with features designed to better grip thetendon graft, such as protrusions, spikes, roughened surfaces, etc.Alternatively, the tip may be applied with a lancing tool that deflectsa small portion of the metal into the tendon graft, thus providingbetter retention. Many other tip attachment methods may be employed suchas the use of staples, clips or sutures. The tip may be elongated suchthat the length is many times it's width to provide a longer effectivestiff section for easier interface with a connector.

FIG. 80 shows the tendon allograft 860 with a tip attached using asuture strand 866 passed through holes in the tip. The tip 862 withattached allograft 860 is shown passed through the receiving slot of theconnector 864. The connector 864 of this embodiment may be similarlyconfigured as connectors described previously herein. However, the slotsand openings on the connector through which the allograft passes may beof greater width to allow for passage of the thicker (by comparison tothe prostheses described herein) tendon graft.

FIG. 81 is a continuation of FIG. 80 wherein a tendon graft 860 is shownaffixed using a connector 864 configured to accept the graft. The tendongraft 860 has been placed under the cleat 870 on the connector 864which, as described earlier, is a temporary or provisional locking mode,since it is still easy to adjust. The tip from FIG. 80 has been cut offor otherwise removed, leaving a free edge 872 of the tendon graft. Thedistal end 874 of the tendon graft 860 has been passed thought theopposite slot 875 of the of the connector, folded back onto itself andaffixed using suture. This is the non-detachable end of the assemblywhich may be affixed prior to passing the tendon graft around thecoracoid and clavicle bones (not shown).

FIG. 82 shows the tendon graft/connector assembly of FIG. 81 in apermanently locked stated. The cleat 870 has been deflected, effectivelylocking the tendon graft in place. Additional tacking sutures 878 areshown in place to provide additional fixation if required. These suturesmay be passed through small openings 880 in connector.

We turn now to other orthopedic applications and embodiments. Thepassing device described previously for circumventing bones in theshoulder is also useful for passing a suture around other bones orobjects. The passing device can, for example, be used to circumventother bones for other orthopedic procedures, specifically traumaapplications. The femur bone in particular is subject to high loads andoften fractures in a manner that requires repair. One common type offemur fracture, a periprosthetic fracture, occurs in patients with priorhip replacements. The stem of the prosthetic hip implant is imbeddeddeep into the femur bone and subsequent loading and anatomicalconditions sometimes results in the femur bone fracturing or splinteringaround the prosthetic. In these cases, is becomes necessary to repairthe fracture, often with circumferential cables which are sometimescombined with bone plates. The placement of the cables around the femuris technically demanding and the current passing tools are invasive anddifficult to use. Embodiments of the passing tool described previouslyin this application have utility in this application.

FIG. 83 shows a femur bone 900 with a fracture 902. A passing device 904of substantially the same design as disclosed previously herein is shownwith the cannula 906 adjacent the femur bone. A passing element 908 iscarried around the bone by the shape memory element 910 in the fashiondescribed previously in this application. The passing element of thisembodiment may differ from previously described embodiments in that itmay not only be larger (the femur is a large bone) but also wider andthicker, resulting in a stiffer, stronger loop when deployed, yetremaining within the 8% strain limit as described previously.

FIG. 84 is a continuation of FIG. 83 wherein the passing element hasbeen delivered around the bone, the shape memory element retracted, andthe passing device removed from the field. The passing element 908 isshown with a free loop 904 on one end and a cerclage cable 904 attachedto the other loop. A cerclage cable is a typically braided metal wireused in orthopedic trauma application. In other embodiments a cerclagecable may be attached directly to the end of the shape memory elementfor circumvention of the bone, thus not requiring the use of the passingelement.

FIG. 85 is a continuation of FIG. 84 showing the cerclage cable 914pulled completely around the bone by the passing element 908. Once theappropriate cables have been placed they are generally cinched to reducethe fracture and affixed with a crimp device or terminated at a boneplate.

FIGS. 86 and 87 show two different embodiments of attachment featuresfor attaching a cerclage cable to a passing element. In the firstembodiment shown in FIG. 86, the cerclage cable 916 is configured with atip 918 which has a hole 920 in it. This hole allows the passing elementto be attached to the cable in a luggage-tag configuration 922.Alternatively, the passing element could be passed through the hole andknotted, such that the knot cannot pass back through the hole. In thesecond embodiment shown in FIG. 87, the cable 924 is configured with atip 926 that has button 928 or boss protruding from it. The passingelement loop 930 may then be simply placed around the button.Alternatively, in embodiments, the passing element may be configuredwith connector elements which allow attachment of a cerclage cable. Saidconnecter element may take the form of a female connector which isdesign with an open distal end, the opening sized to accept the tip of acerclage cable. The connector tapers to a smaller diameter back from thefemale opening to transition smoothly into the passing element. Such ataper allows smooth pull-through of the cerclage cable when being pulledaround a bone and through soft tissue, lowering the required force andpreventing snags. The female connector at the distal tip of the passingelement may also be configured so as to securely retain the tip of thecerclage cable. This may be accomplished through a friction fit,utilizing polymers or rubbers with a high coefficient of friction.Alternatively, it may be accomplished with the use of a flexible,braided or woven tubular construct made from polymers typically used insuture products such as PET or UHMWPE. In such a braided female tubularconnector, the retention of the cerclage cable is accomplished when thebraided female connector is placed in tension, thus decreasing thediameter of the braid and effectively hugging the outer diameter of thecerclage cable which is placed inside the tubular structure. In otherembodiments, the female connector for attaching the cerclage cable maybe molded from polymers or rubbers and may have a variety of otherpositive engagement features which retain the cerclage cable within thefemale connector.

As described previously, cerclage cables may be passed with the aid ofthe device of the present invention and affixed to a bone plate toreduce a fracture. FIG. 88 shows an embodiment of a bone plate systemwhich utilizes a prosthetic band as described previously herein. Shownis a fractured femur bone 940 with a bone plate 942 which is affixedwith multiple prosthetic bands 944 of a design described earlier in thisapplication. The prosthetic bands are affixed to the bone plate using alocking cleat mechanism as described in association with connectors andplates earlier in this application. The prosthetic bands areadvantageous in that they are wider than cerclage cables, thus betterdistributing the load. Additionally, the inherently soft nature of theprosthetic band would eliminate sharp ends at the terminations pointswhich can irritate surrounding soft tissue.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A passing device, comprising: a cannula; a shapememory element within the cannula having a loop formed in a distal end;and a passing element attached to a distal end of the loop and attachedto an anchor at a proximal end of the shape memory element, the anchormounted and configured to move with the shape memory element as theshape memory element is extended along the cannula; wherein a distal endof the shape memory element comprises a passing element retentionfeature for retaining the end of the passing element.
 2. The passingdevice of claim 1, further comprising an extension mechanism forextending the shape memory element along the cannula.
 3. The passingdevice of claim 2, further comprising a retraction mechanism forretracting the shape memory element along the cannula.
 4. The passingdevice of claim 2, wherein the extension mechanism is configured toincrementally index the shape memory element along the cannula.
 5. Thepassing device of claim 1, wherein the shape memory element comprisesnitinol.
 6. The passing device of claim 5, wherein the nitinol comprisesan Austenite Finish (Af) Temperature temperature in the range ofapproximately 0° C. to approximately 20° C.
 7. The passing device ofclaim 1, wherein the anchor further comprises a spool for receiving andtightening the passing element onto the loop.
 8. The passing device ofclaim 1, further comprising a bone positioning feature at the distal endof the cannula, the bone positioning feature aiding in positioning ofthe distal end of the cannula against a bone.
 9. The passing device ofclaim 1, further comprising a passing element control feature at thedistal end of the cannula, with the passing element control featureguiding the passing element to a center of the cannula and a center ofthe shape memory element.
 10. The passing device of claim 1, wherein theloop of the shape memory element is bent similar to a shepherd's hook.11. The passing device of claim 1, wherein the passing element retentionfeature comprises opposing slots on opposite sides of the shape memoryelement.
 12. The passing device of claim 1, wherein the passing elementretention feature comprises a notch at a distal tip of the shape memoryelement.
 13. The passing device of claim 1, wherein the passing elementcomprises anchoring elements at opposite ends for attaching to theanchor and the distal end of the shape memory element, respectively. 14.The passing device of claim 13, wherein the anchoring elements compriseopposite ends of a single loop forming the passing element.
 15. A methodfor placing a passing element around a bone of an animal, comprising:using a passing device, inserting a shape memory element via a cannulaadjacent one side of a bone of the animal, said shape memory elementcarrying a passing element, the shape memory element comprising a curvedshape and formed of a material flexible enough to conform to the shapeof the cannula while retracted, and the shape memory element having aresilience to return to the curved shape upon extending out of thecannula; incrementally extending the shape memory element out of thepassing device and at least partially around the bone, the curved shapeof the shape memory element curving around the bone due to resilience ofthe shape memory element; detaching the passing element from the shapememory element; and retrieving the passing element from generally a sideof the bone opposite the one side.
 16. The method of claim 15, furthercomprising retracting the shape memory element back into the cannula,wherein at least a portion of the curved shape flexes to conform to theshape of the cannula.
 17. The method of claim 15, wherein the first boneis a coracoid, and the second bone is a clavicle.
 18. The method ofclaim 15, wherein the first bone is a tibia, and the second bone is afibula.
 19. A passing device, comprising: a cannula; and a shape memoryelement within the cannula having a loop formed in a distal end, theshape memory element comprising a material such that when the loop isretracted within the cannula, the loop has a strain more than 2% and thematerial having sufficient radial stiffness to resist bending of theloop while being deployed through tissue around a bone.
 20. The passingdevice of claim 19, wherein a distal tip of the shape memory element isbent similar to a shepherd's hook.